FDA warns Lunesta sleeping pill users: Take half the dosage

From The Washington Times:

The Food and Drug Administration warned that anyone prescribed the sleeping medication Lunesta might want to start their dosages at half strength, to about 1 milligram.

The federal agency ordered the manufacturer, Sunovion Pharmaceuticals, to change its warning labels to reflect the new FDA recommendations, which are a scale-back of the current 2 milligram dose, The New York Times reported.

The FDA’s latest recommendation comes in part from research that involved 91 adults at the Surrey Clinical Research Center in Britain. The study found that 3 milligrams of Lunesa impairs memory and motor skills the next day and that the recommended 2 milligrams could prove a challenge for driving, memory and fine-motor skills for up to 11 hours after ingesting.

Posted: 5/16/2014 9:44:00 AM

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FDA Approval of Paroxetine for Menopausal Hot Flushes

From The New England Journal of Medicine:

The recent approval by the Food and Drug Administration (FDA) of paroxetine (Brisdelle, Noven) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause was distinctive for at least two reasons. First, it offered the first nonhormonal option to women who cannot or do not want to use hormonal medications to treat their menopausal vasomotor symptoms. Second, the approval ran counter to the recommendation of the FDA Reproductive Health Drugs Advisory Committee, which had concluded, by a vote of 10 to 4, that the overall benefit–risk profile of Brisdelle did not support approval.

For decades, hormonal therapy had been the only FDA-approved treatment for menopausal vasomotor symptoms. Hormonal therapy is highly effective for treating vasomotor symptoms, but health risks in some women became apparent about a decade ago, with the release of reports from the Women's Health Initiative. Owing to these reports, many women either have chosen not to use hormonal therapy to treat their symptoms or have not been offered such therapy because of coexisting conditions. Overall, use of hormonal therapy has decreased considerably in the past decade — a trend that underscores an unmet need for a nonhormonal treatment option for vasomotor symptoms.

The efficacy of Brisdelle was established in two randomized, double-blind, placebo-controlled, multicenter clinical trials. More women who used Brisdelle than women who used placebo considered the reduction in frequency of their hot flushes to be clinically meaningful. In addition, Brisdelle remained efficacious at 6 months, the latest time point assessed. This is an important finding, because a lack of efficacy at 6 months after treatment initiation would call into question its usefulness for this fairly chronic condition.

Brisdelle's modest efficacy and concerns about suicidal ideation certainly influenced the advisory committee's 10-to-4 vote against approval. But recognizing that no hormone-free drug product had been approved to treat vasomotor symptoms, and after careful review of the efficacy results, the FDA concluded that Brisdelle offers a clinically meaningful benefit for some menopausal women. In addition, the Brisdelle clinical trials did not identify any new safety concerns regarding paroxetine.

Posted: 5/8/2014 1:39:00 PM

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Designer drugs put youths at risk, but recipe changes tie officers’ hands

Via Dallas News

 A week before he died, the 15-year-old honors student had taken an illustrated book to pastures near his Frisco home looking for psychedelic mushrooms. He didn’t find any, so he tried what he thought was LSD on Dec. 14. Convulsions began within an hour after he ingested 25I, a synthetic hallucinogen more potent than LSD. The Collin County medical examiner ruled that his death was connected to the drug. In what appears to be a growing problem, three more overdoses possibly linked to 25I were reported in McKinney last weekend. They appear not to have been fatal.

Efforts to criminalize emerging designer drugs in Texas fell flat in the most recent legislative session, making it more challenging for law enforcement agencies to crack down on the problem.

Nationally, at least 19 deaths have been linked to a set of synthetic drugs known as the NBOMe compounds, including 25I, according to the Drug Enforcement Administration. The users ranged from 15 to 29 years old. Texas Poison Control Network has tallied 25 calls related to NBOMe since 2012. Six came from the Dallas-Fort Worth area.

Stymied in Austin

In November, the DEA temporarily added three NBOMe drugs to Schedule I.  In February, the Department of State Health Services added three NBOMe compounds to the state’s list of controlled substances. The temporary move allows prosecutors to pursue criminal charges, but only misdemeanors, regardless of the amount of the drugs.

Though the state banned K2 in 2011, other kinds of “fake pot” have surfaced since. And if the chemistry is slightly different from what’s in the law, dealers can avoid prosecution.

Law enforcement and public health officials said Huffman’s bills would address that problem by outlawing certain designer drugs and other compounds with the same core chemical structure.

Dueling experts

Like the federal government, Texas has provisions to cover analogs — drugs that are substantially similar to some illegal substances based on their chemical makeup or effects on users.

For every case, prosecutors would have to prove in court that the compound in question was similar enough to an illegal narcotic.

“It comes down to a battle of the expert witnesses,” said Samms, who wrote to lawmakers in support of Huffman’s proposed legislation.

And some cases don’t even make it to court if law enforcement or health officials can’t trace a drug.

NMS Labs in Pennsylvania, which does forensic testing for medical and legal clients across the country, handled its first NBOMe case in 2012.

“They’re very potent, so it takes very little drug to have its effects,” toxicologist Donna Papsun said. “The challenge was creating a test with a low enough detection level so we could properly detect it in the fluids.”

Posted: 4/22/2014 10:42:00 AM

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New synthetic drug investigated in Fishers teen’s death

From: Fox59

HAMILTON COUNTY, Ind. - Police have opened a criminal investigation into the death of a Hamilton County teen who made have died after ingesting synthetic drugs.

John Joseph Romaine, 18, was found unresponsive in his Fishers home Friday evening. According to his obituary, the Hamilton Southeastern High School senior died of cardiac arrest. The Hamilton County coroner is waiting on toxicology results before ruling an official cause, but police are looking into a possible overdose of synthetic drugs.

Police told FOX59 they found illegal drugs inside the home along with three men, including Romaine, who was unconscious.

Officers got there and observed a male lying on the floor and immediately began CPR until medics arrived," said Officer James Alvis, a spokesman for Fisher Police. All three were hospitalized, and Romaine was later pronounced dead.

A Reddit post, which appears to be written by Romaine's older brother, describes the night in detail and points the blame on a new synthetic drug called N-Bomb or NBOME. The author warns people not to use the drug and expressed deep regret over his brother's death.

FOX59 went to St. Vincent Carmel Hospital to find out more about the drug. Emergency room physician Dr. Marcus Hendry explained that it's a psychedelic drug that is often compared to LSD, but it is considered more powerful depending on the purity and dosage.

"They might experience agitation, hallucination, might get high fever, muscle injury, kidney failure, all the way to persistent seizures that may require the induction of a medical coma or even death as a result of persistent seizures or perhaps more commonly death." explained Hendry.

Police are now looking into the Reddit post and warning parents and teens to consider how dangerous synthetic drugs can be. They have not ruled out any arrests in this case.

Posted: 4/10/2014 2:18:00 PM

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Student fell to death after eating weed cookie

From theGrio:

An autopsy report lists marijuana intoxication as a “significant contributing factor” in the death of 19-year-old Levy Thamba Pongi, a native of the Republic of Congo who fell from a motel balcony on March 11.

Levy was a Wyoming college student who was visiting Denver on spring break. Investigators believe Pongi and his friends came to Colorado to try marijuana, Weiss-Samaras said.

Colorado legalized recreational sales of the drug in January. Colorado law bans the sale of recreational marijuana products to people under 21. It is also illegal for those under 21 to possess marijuana, and adults can be charged with a felony for giving it to someone under the legal age.

Authorities said one of Pongi’s friends was old enough to buy the cookie from a pot shop. It was unclear whether the friend might face charges.

It marked the first time the Denver medical examiner’s office has listed a marijuana edible as a contributor to a death, said Michelle Weiss-Samaras, a spokeswoman for the office.

The medical examiner’s office had Pongi’s body tested for at least 250 different substances, including bath salts and synthetic marijuana, which are known to cause strange behavior. His blood tested positive only for THC, the psychoactive ingredient in marijuana, according to the report.

The marijuana concentration in Pongi’s blood was 7.2 nanograms of active THC per milliliter of blood. Colorado law says juries can assume someone is driving while impaired by marijuana if their blood contains more than 5 nanograms per milliliter of the chemical.

Posted: 4/9/2014 2:58:00 PM

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School Board Votes to Test Student Athletes for Synthetic Drugs

From: Independant Herald

Synthetic drugs have been added to the substances for which Wyoming County student-athletes may be tested. The Board of Education unanimously approved the addition to the drug testing program at its meeting last Monday night.

“The normal test drugs did not include the synthetic drugs,” said Superintendent of Schools Frank “Bucky” Blackwell.

“Mr. (Jeff) Hylton wanted the board to know that the synthetic drugs are gaining in popularity,” he added. “It’s not actually detected under a regular drug test.

“Anybody who might be using the synthetic drugs would just go scot free,” Blackwell said. “Our whole goal is to catch it in time so that something could be done about it before it gets out of hand or somebody overdoses or has an accident.”

Testing for synthetic drugs is twice as costly as the regular testing, Blackwell noted, “Hopefully the costs will come down.”

“We’ve had great results,” the superintendent remarked. “We don’t catch too many, but we’ve never had a repeat offender.”

If there is a positive test result, Blackwell said, “you have to call Mom and Dad and law enforcement.

“That’s a shocker,” he continued. “Most parents have no idea their child would do something like that. As it has turned out, we have stopped a lot of kids from using drugs.”

Students who test positive are expelled, he pointed out, “and they have straightened up.”

With the addition of synthetic drugs, a student-athlete may be tested for one type of drug or both, Blackwell explained.  “We don’t pick up the phone and ask [the company] to test unless someone is behaving in such a way that would indicate they have a problem.”

He says the board “backs the program 100 percent. It’s paying dividends for our children.

“We feel we have to what we can to help prevent the use of drugs,” Blackwell observed.

Written by John Conely
___________________________________________________________________

This is a great step in the right direction to helping solve the problem of designer drugs, especially with our youth.  Hopefully other districts will join suit and help convey the message that even though some of these drugs may be legal they are still very dangerous and shouldn't be used.
 

Experts Warn of Synthetic Drug Acetyl Fentanyl

From EMS World:

Officials in North Carolina announced they were on the lookout in March for a drug called acetyl fentanyl, which they blame for three deaths in the state.

A CDC health advisory released June 20, 2013 first warned of the drug. “Recently, a number of intravenous drug users have overdosed on a new, non-prescription injected synthetic opioid, acetyl fentanyl,” the release stated.

Between March 2013 and May 2013, 14 overdose deaths related to injected acetyl fentanyl occurred among intravenous drug users in Rhode Island.

When Pennsylvania asked coroners and medical examiners across the state to screen for acetyl fentanyl, the request led to 50 confirmed fatalities and five non-fatal overdoses statewide in 2013, the CDC later reported.

The CDC’s warning recommends increased vigilance by public health agencies, emergency departments, state laboratories, medical examiners and coroners for patients with symptoms consistent with opioid overdose and lab results showing an enzyme-linked immunosorbent assay (ELISA) positive for fentanyl.

Posted: 4/2/2014 11:30:00 AM

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New Synthetic Drug Linked To Teen's Death

From WBIW (Indiana):

Police have opened a criminal investigation into the death of a Hamilton County teen, who made have died after ingesting synthetic drugs.

18-year-old John Joseph Romaine was found unresponsive in his Fishers home Friday evening. According to his obituary, the Hamilton Southeastern High School senior died of cardiac arrest. The Hamilton County coroner is waiting on toxicology results before ruling an official cause, but police are looking into a possible overdose of synthetic drugs.

Police said they found illegal drugs inside the home along with three men, including Romaine who was unconscious.

All three were hospitalized, and Romaine was later pronounced dead.

A Reddit post, which appears to be written by Romaine's older brother, describes the night in detail and points the blame on a new synthetic drug called N-Bomb or NBOME.

E.R. Physician Dr. Marcus Hendry explained that it's a psychedelic drug that is often compared to LSD, but it is considered more powerful depending on the purity and dosage.

Posted: 4/2/2014 10:46:00 AM

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Toward a Pill That Helps Us Learn as Fast as Kids

From The Atlantic:

Shannon, a 14-year-old who lives in Massachusetts, has amblyopia, a condition sometimes referred to as “lazy eye.”

Patients’ best hope for correcting amblyopia is before they turn about 8 years old. Those who don’t get treatment early enough—or for whom treatment doesn’t work—usually end up living with the problem forever.

Shannon is one of those people. Her entire life, she’s worn glasses with a thin non-prescription lens on one side, and a thick corrective lens on the other. As a toddler, her parents tried to make her wear therapeutic eye patches, but she would fling them off.

A few months ago, Shannon enrolled in a clinical study at Boston Children’s Hospital for which she’s taking donepezil, a drug that’s typically used to treat Alzheimer’s. Donepezil is a cholinesterase inhibitor, meaning it increases the amount of acetylcholine circulating around nerve endings. It's been shown to improve memory function in some patients with dementia.

But of course, Shannon doesn’t have memory problems. Her team of doctors is instead using the donepezil to encourage her brain to learn new skills as quickly and nimbly as an infant’s would. Shannon's vision has improved markedly over the past four months, her mother told me by phone.

Takao Hensch, a Harvard professor of cellular biology who is part of the Boston Children’s team, has found that behavioral drugs like donepezil can help return the chemistry of the brain to so-called “critical periods” in its development—the times during early childhood when the brain was rapidly growing. Critical periods help explain why children younger than about 7 can pick up new skills, like language and music, much faster than adults can. This is why you see parents attempting to plant foreign languages in their kids while they’re still in Pampers. It’s much easier than trying to conjugate French verbs for the first time when you’re 30.

Hensch and his colleagues have already found that valproate, an epilepsy drug, can help tone-deaf adults learn to differentiate music notes. In a study published in December in the journal Frontiers in Systems Neuroscience, a team of researchers including Hensch administered valproate or a placebo to 24 men with no music experience and then trained them to label music notes. Those who took the valproate were later able to correctly identify 5.09 music notes on average, compared with 3.5 in the control group.

There were several flaws in the study—the sample size was small, and it’s possible that some of the men had a genetic predisposition toward music.

Still, the effect size was promising enough for Hensch to attempt new experiments with other drugs and different types of traits.

The psych meds work by boosting the molecules, such as serotonin and acetylcholine, that are normally dampened during adulthood. The extra surge of chemicals aids in the rewiring process.

E-cigarettes’ liquid drug can also kill

From The Boston Globe:

A dangerous new form of a powerful stimulant is hitting markets nationwide, for sale by the vial, the gallon, and even the barrel.

The drug is nicotine, in its potent, liquid form — extracted from tobacco and tinctured with a cocktail of flavorings, colorings, and assorted chemicals to feed the fast-growing electronic cigarette industry.

These “e-liquids,” the key ingredient in e-cigarettes, are powerful neurotoxins. Tiny amounts, whether ingested or absorbed through the skin, can cause vomiting and seizures and even be lethal. A teaspoon of even highly diluted e-liquid can kill a small child.

But like e-cigarettes, e-liquids are not regulated by federal authorities. They are mixed on factory floors and in the back rooms of “vaping” shops, and sold legally in stores and online in small bottles that are kept casually around the house for regular refilling of e-cigarettes.

Evidence of the potential dangers is emerging. Toxicologists warn that e-liquids pose a significant risk to public health, particularly to children, who may be drawn to their neon-bright colors and fragrant flavorings like cherry, chocolate, and bubble gum.

Reports of accidental poisonings, notably among children, are soaring.

Recreational use of liquid nicotine has in effect created an entire new drug category, and a controversial one. For advocates of e-cigarettes, liquid nicotine represents the fuel of a technology that might prompt people to quit smoking, and there is anecdotal evidence that is happening. But there are no long-term studies about whether e-cigarettes will be better than nicotine gum or patches at helping people quit. Nor are there studies about the long-term effects of inhaling vaporized nicotine.

Unlike nicotine gums and patches, there also is no regulation of e-cigarettes or their ingredients. The Food and Drug Administration has said it plans to regulate e-cigarettes but has not disclosed how it will approach the issue. Many e-cigarette companies hope there will be limited regulation.

Posted: 3/24/2014 2:29:00 PM

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